The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Reported: August 22, 2018 Initiated: May 17, 2018 #Z-2835-2018
Product Description
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Reason for Recall
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1
- Distribution
- U.S.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.. Recalled by Intuitive Surgical, Inc.. Units affected: 1.
Why was this product recalled? ▼
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2835-2018.
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